Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02195206
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2014-06-19
Brief Title:
Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging Healthy Adult Volunteer Pilot Study
Sponsor:
The Hospital for Sick Children
Organization:
The Hospital for Sick Children
Study Overview
Official Title:
Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging Hardware and Software Healthy Adult Volunteer Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this pilot study MRI of the lungs of healthy adult volunteers will be performed at 3Tesla to assess image quality using a prototype chest coil and pulse sequence following inhalation of hyperpolarized 129Xe xenon gas This study will take place at the Hospital for Sick Children Toronto Canada Thirty two subjects aged 18 to 75 will participate in this study Xenon MRI is a non-invasive imaging technique that does not involve X-rays or ionizing radiation Rather this imaging method utilizes the same hardware and software principles that are used for conventional proton MRI of patients in a hospital The investigators are testing the abilities of xenon MRI to see if it will produce lung images of equal or better quality to that of proton MRI
The investigators hypothesize that they will get good quality images of the lungs for analysis using our method
The investigators hypothesize that they will get good quality images of the lungs for analysis using our method
Detailed Description:
With the emergence of novel hardware and software image acquisition improvements magnetic resonance imaging MRI has the potential to become an important tool for assessing lung structure and function In particular the use of a hyperpolarized noble gas such as 129Xe has been used to explore structural and functional relationships in the lungs of both healthy subjects and patients with lung disease 12 In contrast to proton-based MRI imaging 129Xe gas is used as a contrast agent to directly visualize the airways and thus image ventilation Whereas the normal density of gas is too low to produce an easily detectable signal this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping 3
Hyperpolarized noble gas MR lung imaging is a relatively new imaging method that allows depiction of both lung function and morphology 4-9 Hyperpolarized gases are a new class of MR contrast agent which when inhaled provide high temporal and spatial resolution MR images of the lung airspaces Since no ionizing radiation is involved hyperpolarized gas MR imaging is ideal for the evaluation of lung diseases With hyperpolarized gases the nuclear spins of the gas atoms are brought into alignment outside of the MR scanner via a process called optical pumping this yields high polarizations and permits visualization of the lung airspaces with MR imaging despite the low physical density of the gas in the lung Two non-radioactive ie stable isotopes of noble gases 3He and 129Xe can be hyperpolarized Until recently higher polarizations could be achieved with 3He than with 129Xe so in humans 3He was more commonly used for hyperpolarized gas MR imaging of the lungs 10-15 Recently the technology has been developed to provide large quantities of highly polarized 129Xe 16
Several applications of 129Xe MRI imaging are under development including diffusion-weighted and relaxation-weighted imaging 17-19 These techniques take advantage of the fact that the rate of loss of 129Xe polarization is significantly influenced by the local blood flow and concentration of molecular oxygen as well as the restriction of 129Xe diffusion by small airway space dimensions These data can be used to create maps of the lung reflecting regional ventilationperfusion and micro-airway sizes Other data that can be obtained with 129Xe MRI include the volumes of ventilated and unventilated lungs which can subsequently be analyzed to determine the homogeneity of gas distribution within the airspaces 17
Objectives of the study are
To quantitatively evaluate a 3T 129Xe chest coil for image quality and coil comfortperformance
To determine the range of possible novel pulse sequences in combination with the coil and inhalation of 129Xe gas in healthy volunteers
Hyperpolarized noble gas MR lung imaging is a relatively new imaging method that allows depiction of both lung function and morphology 4-9 Hyperpolarized gases are a new class of MR contrast agent which when inhaled provide high temporal and spatial resolution MR images of the lung airspaces Since no ionizing radiation is involved hyperpolarized gas MR imaging is ideal for the evaluation of lung diseases With hyperpolarized gases the nuclear spins of the gas atoms are brought into alignment outside of the MR scanner via a process called optical pumping this yields high polarizations and permits visualization of the lung airspaces with MR imaging despite the low physical density of the gas in the lung Two non-radioactive ie stable isotopes of noble gases 3He and 129Xe can be hyperpolarized Until recently higher polarizations could be achieved with 3He than with 129Xe so in humans 3He was more commonly used for hyperpolarized gas MR imaging of the lungs 10-15 Recently the technology has been developed to provide large quantities of highly polarized 129Xe 16
Several applications of 129Xe MRI imaging are under development including diffusion-weighted and relaxation-weighted imaging 17-19 These techniques take advantage of the fact that the rate of loss of 129Xe polarization is significantly influenced by the local blood flow and concentration of molecular oxygen as well as the restriction of 129Xe diffusion by small airway space dimensions These data can be used to create maps of the lung reflecting regional ventilationperfusion and micro-airway sizes Other data that can be obtained with 129Xe MRI include the volumes of ventilated and unventilated lungs which can subsequently be analyzed to determine the homogeneity of gas distribution within the airspaces 17
Objectives of the study are
To quantitatively evaluate a 3T 129Xe chest coil for image quality and coil comfortperformance
To determine the range of possible novel pulse sequences in combination with the coil and inhalation of 129Xe gas in healthy volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None